SOLIFENACIN SUCCINATE

Product NDC
63629-8532
11-digit product format
636298532
Labeler code
63629
Product ID
63629-8532_f1a70279-30d4-4c00-a28e-4434b85d5ced
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SOLIFENACIN SUCCINATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211657
Marketing category
ANDA
Marketing start
2019-05-20
Substance
SOLIFENACIN SUCCINATE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOLIFENACIN SUCCINATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKKA5DLD701
Rxcui477367

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8532-1SOLIFENACIN SUCCINATE30 in 1 BOTTLETABLET, FILM COATED30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8532-1EA - Each63629-8532e6f2648d-3af7-4fd3-ab77-0491429c0a4e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8532SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_49346a96-3d96-4702-b96e-94e635510dba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477367solifenacin succinate 5 MG Oral TabletPSN49346a96-3d96-4702-b96e-94e635510dba102
477367solifenacin succinate 5 MG Oral TabletSCD49346a96-3d96-4702-b96e-94e635510dba102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8532-16362985320130 TABLET, FILM COATED in 1 BOTTLE (63629-8532-1) 2021-05-190000-00-00NoNoCurrent